Self-management of Anticoagulation Treatment

Not Applicable

Completed

• Conditions: Artificial Heart Valve; Venous Thromboembolism; Atrial Fibrillation
• Interventions: Other: Training

• Registration Number: NCT02864537
• Lead Sponsor: University of Bergen

Brief Summary

The aim of the study was to compare self-management of anticoagulant treatment with conventional anticoagulant treatment in Norway.

Detailed Description

Patients (n=132) on anticoagulant treatment with warfarin participated in a 21 weeks training program where they learned how to analyse International Normalised Ratio (INR) using the point-of-care instrument CoaguChek®XS and dose warfarin. The patients had to display their skills through a test before considered self-managing. They continued to measure INR weekly for two years. All INR values during the training program and self-control period were collected. In addition, the patients were told to notify if they had any complications during this period. INR values and complications two years before enrolment was collected from INR cards and/or their general practioner. The participant filled in a quality of life-questioner at enrolment and after two years of self-management.

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2016-08
• Study First Submitted: 2016-08-09
• Study First Submitted QC: 2016-08-09
• Last Update Submitted: 2016-08-09
• Study First Posted: 2016-08-12
• Last Update Posted: 2016-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• On life-long oral anticoagulation therapy
• Judged to be qualified for patient self-management anticoagulation treatment by their GP
• Motivated to follow the training program

Exclusion Criteria

• Drug abuse
• Liver disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Self-management	Training	Trained to monitor INR and dose warfarin

Primary Outcome Measures

Name	Time	Method
Change in Time in therapeutic range (TTR)	From two years before enrolment until two years of self management	Change in TTR from conventional treatment to self-management

Secondary Outcome Measures

Name	Time	Method
Quality of life (QoL)	Baseline before training and after two years with self-management
Change in number of complications	From two years before enrolment until two years of self management	Compare number of complications during conventional treatment and during self-management